China's New Disinfection Product Approval: Public Record, 2014–2026

The Public Record, 2014–2026

China publishes an announcement each time it accepts an application for a new disinfection product. Between December 2014 and February 2026, 39 such announcements were published.

Acceptance for review means the application has been formally received and has entered the review process. It does not mean the product has been approved.

The published record shows the following patterns:

Applications arrive in waves. The published record shows nothing between 2015 and 2018, then 12 in 2020 alone, as the pandemic drove interest in novel disinfection technology. The volume has since settled at a few a year.

Imported products make up most of the recent volume. Only five of the 39 announcements are for imported products, but three of the last four are.

The early records have an important limitation: the platform's record of the documents it sent to applicants shows at least two more products, from 2014–2015, that never appear in the acceptance announcements. The archive is therefore incomplete for that period. The figures above show what was published, not necessarily everything that was accepted.

Review Outcomes in the Public Record

Being accepted for review is only the first step. The same platform also publishes notices about the documents it sends to applicants while the review is under way. Between 2015 and February 2022, those notices cover:

• 3 decisions refusing a licence — for a liquid disinfectant, a household air disinfection machine, and a photocatalytic air disinfection machine, all accepted in 2020;

• 8 sets of review comments sent to applicants, in several cases more than a year after acceptance;

• 5 notices extending the review period, with two products receiving two of them each.

The First Approval and Its Regulatory Implications

The approval concerned a liquid disinfectant developed by Anhui Qiwei Biotechnology, registered under the Chinese name 蓝杉®埃芙莫拉消毒液. Its application acceptance number, 卫消申字(2021)第0007号, appears in the annex to this article, and the application was accepted in August 2021. The NCDPA approved the product on 14 August 2024 and announced it in NCDPA Announcement No. 1 of 2024, dated 11 October 2024:

The announcement states that, from its publication date, disinfection products manufactured using the specified ingredient are no longer subject to administrative licensing as new disinfection products.

The announcement identifies the ingredient, named 埃芙莫拉 in Chinese, as a quaternary ammonium salt with the formula C₂₁H₄₄NO₂SCl and the CAS number 2540340-97-2.

The announcement has two implications: the product is approved, and the ingredient stops being treated as a new material and joins the list of permitted raw materials. Products built on the same ingredient afterwards, including the applicant's own, can then be filed in the ordinary way instead of going through this review again.

Definition of a New Disinfection Product

The route is defined by three tests. A product falls within it if it meets any one of them:

• New material — an active ingredient that appears on none of the following: the list of permitted disinfectant raw materials, the disinfectant and preservative category of the Chinese Pharmacopoeia (the government's official drug reference), and current national hygiene standards;

• New production process — a change in technical parameters or process flow that makes the product equal or superior to conventional products in effectiveness, safety and environmental adaptability;

• New disinfection principle — a way of killing microorganisms, or a test indicator for it, that is not covered by the existing official lists of disinfection factors, devices and indicators.

These tests are worth applying early, and against the Chinese lists rather than against your home market. A product is not new because its marketing is new, or because its ingredient is unfamiliar elsewhere.

What the Pathway Means for Companies

For companies developing products that meet China's definition of a new disinfection product, national approval is the applicable market-access pathway. The 2024 case also shows why applicants should review the wording of the subsequent announcement: it specifies how products manufactured using the announced ingredient are treated under the new-product licensing regime.

What to Expect in Review

The published record is a useful source of evidence about the review process and should be considered when planning an application.

• Time. The approved product was accepted for review in August 2021, received a review-extension notice two months later, and was approved on 14 August 2024. In this case, approximately three years elapsed between acceptance and approval. This case history should not be read as a standard approval timeline.

• Rounds of dialogue. By the applicant's own account, the process involved five rounds of on-site hearings before an expert panel.

• Review comments and extensions. These appear repeatedly in the published record, and some applications drew comments more than a year after acceptance.

The case history indicates that applicants should allow for the possibility of a multi-year process and repeated exchanges with reviewers, and that the dossier must be able to answer an expert committee's questions, not merely satisfy a list of requirements.

Recommended Reading

• China Disinfection Products: What Requires Filing and What Happens If You Don't File?

• China Disinfectant Compliance

Official References

Acceptance announcements and notices about documents sent to applicants, National Health Commission government service platform. NCDPA Announcement No. 1 of 2024, 11 October 2024. Publicity about the company published by the Hefei High-tech Zone authorities.

• NHC Government Service Platform: New Disinfection Product Acceptance Announcements

• NCDPA Announcement No. 1 of 2024, dated 11 October 2024

• NHC Government Service Platform: New Disinfection Product Approval Guide